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Sterols and Stanols in Foods and Dietary Supplements Containing Added Phytosterols: A Collaborative Study
Authors:Cynthia T Srigley  Steven L Hansen  Sean A Smith  Anjalika Abraham  Eileen Bailey  Xiang Chen  Soo Hui Chooi  Lisa M Clement  Michael Dao  Ali Reza Fardin Kia  Barb Mitchell  Mohit Mogla  Juan Antonio Ruano Ortiz  Keith Persons  Edith von Kries  George Ware  Jason Wubben  Richard Cantrill
Affiliation:1. Center for Food Safety and Applied Nutrition, United States Food and Drug Administration (FDA), 5001 Campus Drive, College Park, MD, USA;2. Cargill, Minneapolis Research & Development Center, 14800 28th Avenue N, Plymouth, MN, USA;3. University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals, 196 Innovation Drive, Winnipeg, MB, Canada;4. DSM Nutritional Products, Analytical Sciences, 6480 Dobbin Road, Columbia, MD, USA;5. Nestlé Quality Assurance Centre (NQAC) Shah Alam, Nestlé Manufacturing (Malaysia) Sdn Bhd, Jalan Playar 15/1, P.O. Box 7010, Shah Alam, Selangor, Malaysia;6. Covance, Inc., 3301 Kinsman Boulevard, Madison, WI, USA;7. NQAC, Nestlé India Limited, 11 Firozpur‐Ludhiana Road, Moga, Punjab, India;8. Laboratorio de Analysis de Alimentos, El Zamorano, P.O. Box 93, Km 30 Road from Tegucigalpa to Danli, Tegucigalpa, Honduras;9. Eurofins Nutrition Analysis Center, 2200 Rittenhouse Street, Des Moines, IA, USA;10. BASF Personal Care and Nutrition GMBH, ILL‐ENO/HI‐025, Illertissen, Germany;11. FDA, 60 8th Street NE, Atlanta, GA, USA;12. Archer Daniels Midland Company, Research Division, 1001 N. Brush College Road, Decatur, IL, USA;13. American Oil Chemists’ Society (Retired), 2710 S. Boulder Drive, Urbana, IL, USA
Abstract:An international, multilaboratory collaborative study was carried out to evaluate the performance of Official Method Ce 12‐16 of the American Oil Chemists’ Society (AOCS) for the determination of plant sterols and stanols, collectively referred to as phytosterols, in foods and dietary supplements containing added phytosterols and in the phytosterol food additive concentrates used to prepare such products. AOCS Official Method Ce 12‐16 involves the extraction of free sterols/stanols and saponified steryl/stanol esters followed by the gas chromatographic separation and flame ionization detection of phytosterol trimethylsilyl ether derivatives. A total of 14 laboratories from six countries successfully completed the analysis of collaborative samples of foods (e.g., baked goods, beverages, margarines; n = 9), dietary supplements (n = 5), and phytosterol concentrates (n = 4). Study results for the contents of total phytosterols (weight/weight) were 0.19–8.4% for foods, 8.7–49% for dietary supplements, and 57–97% for concentrates. AOCS Official Method Ce 12‐16 showed acceptable performance for total and individual phytosterols, indicating that this method was suitable for the determination of added phytosterols in a wide variety of market products and concentrates. AOCS Official Method Ce 12‐16 is appropriate for the determination of the five major phytosterols (i.e., campesterol, stigmasterol, β‐sitosterol, campestanol, and sitostanol) that are the subject of the United States Food and Drug Administration's health claim for phytosterols and the reduced risk of coronary heart disease.
Keywords:Gas chromatography  Health claim  Method validation  Phytosterol  Plant sterol  Trimethylsilyl ether  Stanol
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